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Ethicon Media Monitoring 2/27/2018
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As the Government announces a major review into three health scandals... Why did it take watchdogs so long to listen to women harmed by their treatment?
Feb 27, 2018 | The Daily Mail
By Lois Rogers
Prime Minister Theresa May’s sudden decision last week to review official responses to women left crippled by implanted surgical mesh is of little comfort to Dorothy Byrne. -
Chief medical officer addresses `bad use´ of vaginal mesh
Feb 26, 2018 | Press Association (In The Daily Mail)
Women who have suffered serious complications from vaginal mesh may not have been properly counselled about side effects, England’s chief medical officer has said. -
Whistle blower reveals how surgeons deny they use vaginal mesh implants in a play on words
Feb 26, 2018 | Cambs Times
By Kath Sansom
A hospital in Blackpool is refusing to comment on a surgeon there who is denying they use vaginal mesh implants, in a trend being seen in hospitals across Britain, where women are assured the mesh scandal is just “media hype”. -
Vaginal Mesh Problems Prompt a Safety Audit in the UK
Feb 26, 2018 | MD+DI
By Amanda Pedersen
Prompted by public outrage over vaginal mesh complications, the U.K.'s health and social care secretary has called for a National Health System safety audit of the implants, which are used to treat prolapse and female urinary incontinence. -
England’s top doctor reveals she suffered incontinence after her first child was born
Feb 27, 2018 | The Sun
By Nick McDermott
THE country’s top doctor has bravely told how she suffered incontinence after her first child was born. -
Country's most senior doctor reveals her bladder struggles after childbirth
Feb 27, 2018 | The Telegraph
By Laura Donnelly
The country’s most senior doctor has revealed her struggle with incontinence since the birth of her first child, as she said her "heart goes out" to women left in pain by subsequent surgery. -
Researchers trial new pelvic prolapse treatment using stem cells, bioengineering
Feb 27, 2018 | ABC News
There is hope women who suffer from pelvic organ prolapse may be able to avoid surgery in the future after the discovery of a potential new treatment.
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Feb 27, 2018 | The Daily Mail
By Lois Rogers
· Theresa May decided to review responses to women crippled by surgical mesh
· This comes as hundreds of women are suffering after mesh transplants
· However many reported that the NHS ignored their complaints which are now being looked into by watchdogs
Prime Minister Theresa May’s sudden decision last week to review official responses to women left crippled by implanted surgical mesh is of little comfort to Dorothy Byrne.
Dorothy is one of thousands of women who have suffered life-changing problems as a consequence of the use of the little-tested plastic mesh, introduced to treat incontinence or support pelvic organs, typically following damage related to childbirth.
While many women have had no problems with the mesh, in others, for reasons unknown, it’s disintegrated, forming splinters that ‘migrate’, setting up chronic inflammation and causing infection around affected tissue.
In some women the material has damaged bladder and bowel function, or even their ability to walk.
Just before Christmas, Canadian Christina Brajcic, 42, who chronicled her struggle with mesh-related infections that were proving resistant to treatment, died from sepsis.
Dorothy is now seriously ill with heart failure that she’s been told is linked to the chronic infections she suffered as a result of the mesh. A former NHS psychotherapist, she says she reported her problems to the devices watchdog, the Medicines and Healthcare products Regulatory Agency (MHRA). But like others who say reports of their problems were ignored and never recorded, Dorothy, 65, maintains she has ‘never even received a reply’ from the body.
It’s not just the authorities — many women say doctors insisted they were imagining their problems.
In a victory for the Mail’s seven-year campaign highlighting problems with the mesh, Mrs May announced a review into handling of complaints about it.
The review, to be led by former Conservative health minister Baroness Julia Cumberlege, will also look at similar patterns of official inertia in response to concerns about the drug sodium valproate, prescribed for epilepsy, bipolar disorder and migraine. An estimated 7,000 women have given birth to damaged babies since the Seventies as a result of being prescribed the drug, and campaigners claim the authorities knew about the risks but failed to warn women.
The review will also take in the response to a third crisis, involving Primodos, a defective hormone-based pregnancy test used by 1.5 million women in the UK throughout the Sixties and Seventies, now being linked to catastrophic damage to foetuses of those who were pregnant.
Campaigners have called it the hidden thalidomide. The common thread between mesh and the two drug scandals is a long-term unwillingness by health authorities to acknowledge a problem, with the consequence that more women became victims.
Last week the Prime Minister acknowledged this, saying: ‘We do need to see a faster, more understanding response to patients when they raise concerns.’
But these three scandals reflect a greater problem with repeated controversies surrounding defective medical devices and drugs in the UK, such as industrial silicone being used in breast implants, defective metal hip joints that poisoned patients and faulty heart defibrillators. These scandals have raised serious questions about how such devices are monitored — and licensed in the first place.
The MHRA, along with other healthcare regulators around Europe, relies on a network of 59 commercially run ‘notifying bodies’ to approve the safety and efficacy of medical devices.
But as Good Health has reported, the notifying bodies are paid by manufacturers to win approval for their products and the requirements for scientific validation are vague, say experts. Baroness Cumberlege has said she looks forward to undertaking the nine-month review. ‘It’s essential voices are properly heard and that the system learns lessons and makes changes,’ she says.
But for some women whose lives have been destroyed by the mesh, it’s too little, too late. Not least because their cases have dragged on for so long that they’ve run out of time to seek legal redress.
Although she welcomes the review, Kath Sansom of pressure group Sling the Mesh, which has 5,600 members, says many of the women on her database were fobbed off for years by mostly male gynaecologists, who told them their health problems were nothing to do with the mesh.
‘These women are now time-barred from making legal claims,’ she says. ‘Meanwhile, this material is still being used and women are continuing to suffer. In the past hour, I’ve been contacted about a woman rushed into A&E with life-threatening sepsis and another begging for help who says she is on the verge of taking her own life because of the pain.’
Sadly, the review won’t help Dorothy Byrne. ‘My heart has continued to deteriorate because of a series of chronic infections as a result of the mesh,’ she says. ‘They started about a year after I had the surgery, in 2009, and continued more or less continuously until 2013 when I had it taken out. By then the damage was done.’
Dorothy, a mother of two adult children from Seaford, East Sussex, has heart failure caused, she’s been told by her doctors, by the infections she’s suffered.
She is currently in hospital waiting for a heart valve replacement. Like any surgery, it carries risks — an awful irony, given that she’s only in this situation because of her mesh procedure.
Unlike most of the other women who have been victims of the treatment, Dorothy says she did not even need the mesh: ‘I did not have stress incontinence — I had a prolapsed bladder. My consultant said I should have the mesh in case I developed incontinence.’
By the time Dorothy had the mesh removed in 2013, she had endured long periods of treatment for repeated infections linked to the mesh.
She’d also developed heart problems — in 2012 she had needed specialist treatment for sepsis in a high-intensity cardiac care unit. But doctors dismissed her suggestion that her heart problems could be related to the mesh. Her heart continued to deteriorate, and after she switched cardiology teams, she was told her problems were linked to her infections
‘By the time I found a specialist surgeon with the skills to remove the mesh, I was profoundly ill. The surgeon described my reaction to the tape as one of the most toxic she had ever seen.
‘I reported all this to the MHRA but I never even received a reply.’
For veteran anti-mesh campaigner Teresa Hughes, 66, from St Helens, Lancs, the new review is a hollow promise. She has been left crippled and unable to walk after having the mesh implanted almost 14 years ago in 2006.
Repeated attempts to remove the fragmented material from her body have been only partially successful. ‘I have been trying to get this issue on the agenda for such a long time,’ she says.
‘I went to medical conferences to tell doctors about the damage being done. I was moved on by police from outside the MHRA in 2011. I lobbied David Cameron in 2012. I doubt the review will go back far enough to include the damage to people like me.’
Some campaigners also fear the review could end up as a whitewash, pointing to the example of previous reviews.
It is estimated 92,000 women have had the mesh implants since they were introduced in the early Nineties as a cheaper alternative to pelvic repair operations, which involve the patient’s own tissue. Studies have suggested anything between 10 and 40 per cent of patients have suffered damage.
However, a review of the issues by NHS England published last summer did not discuss the safety of the mesh itself, but merely said doctors without special training should no longer use it.
A similar review was carried out in Scotland, where 1,500 women claim they have been damaged by the mesh. The findings of that review, announced last April, that the mesh was essentially safe was dismissed as a whitewash by campaigners. A new review is now underway in Scotland.
Kath Sansom’s concern about the review announced last week is that the ‘bigger problem’ is that the mesh was approved by an MHRA ‘which is not fit for purpose — while many of the women’s complaints have never even been recorded by the MHRA, which is largely funded by drug and device manufacturers.’
Her views are echoed by Mark Harvey, a lawyer for Hugh James solicitors in Cardiff who is representing more than 100 of the 600-plus women expected to launch multi-million pound claims for mesh-related injuries.
‘I was hoping for a proper review of the whole drug licensing system led by a high court judge,’ he said. ‘Now would be the right time to have a complete overhaul because there is a big question mark anyway over what will happen to drug controls after Brexit.’
MHRA chief executive Dr Ian Hudson told Good Health: ‘Our role is not to protect industry interests. It is important to learn from how the healthcare system and regulators have handled these three issues [mesh, sodium valproate and Primodos], including how we ensure the patient voice is carefully heard.
‘We will work closely with the Department of Health and Social Care, the NHS and the wider healthcare system on this review.'
http://www.dailymail.co.uk/health/article-5438429/Government-announces-review-three-health-scandals.html
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Chief medical officer addresses `bad use´ of vaginal mesh
Feb 26, 2018 | Press Association (In The Daily Mail)
Women who have suffered serious complications from vaginal mesh may not have been properly counselled about side effects, England’s chief medical officer has said.
Professor Dame Sally Davies said that she had received “tragic” post from affected women.
But she said that for a select group of women, mesh is the “best treatment”.
Meanwhile she admitted that she herself had suffered incontinence after giving birth.
During a Facebook Live chat with Health and Social Care Secretary Jeremy Hunt, Dame Sally said: “There has been undoubtedly been bad use of vaginal mesh.
“We women after we have had babies can be damaged, so that we have incontinence.
“Actually, and I have never gone public about this – after my first child, I could walk three yards before I peed in my pants.
“For six weeks I could not the leave the house. And I’m still not as I would wish to be so I have every sympathy with these women.
“It’s quite clear that for a selected group of women, the best treatment – if you have got a good doctor – is to have a type of mesh that lifts the bladder up and supports the uterus and makes it all right.
“But even if you have got a good surgeon and the right patient, there are quite a lot of side effects – 15-20% get side effects.”
She said she had received “tragic” letters and emails from women who suffered complications after being fitted with mesh.
“It’s bad enough suffering from incontinence – I know – but who are worse off because of pain,” she said.
“My heart goes out to them.”
She added: “But it is quite clear from the letters that they were not properly counselled about the side effects and that many of these women who have written to me probably did not have the right surgeon and may not have been in the group who should have had it.
“And so we have got to be very careful about the evidence so we don’t stop women who are in the right group with an expert surgeon going for it if they have been counselled about side effects, but on the other hand we protect women from surgeons who may not be fully informed or don’t counsel properly.
“So this is a really difficult area.
“I really was moved by the emails I have had this weekend by women who are in real pain and suffering.”
Last week Mr Hunt launched a review into how the NHS responds to safety concerns raised by patients about medicines or medical devices.
In particular it will look into patient concerns about vaginal mesh along with hormone pregnancy test Primodos and epilepsy drug sodium valproate.
It will also consider whether a full investigation or a public inquiry is necessary into any of the issues.
http://www.dailymail.co.uk/wires/pa/article-5437353/Chief-medical-officer-addresses-bad-use-vaginal-mesh.html
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Whistle blower reveals how surgeons deny they use vaginal mesh implants in a play on words
Feb 26, 2018 | Cambs Times
By Kath Sansom
A hospital in Blackpool is refusing to comment on a surgeon there who is denying they use vaginal mesh implants, in a trend being seen in hospitals across Britain, where women are assured the mesh scandal is just “media hype”.
As the scandal escalates into what is being called the biggest women’s health disaster since thalidomide, some patients are being told their local hospital doesn’t use mesh, it uses tape or a band.
Campaigners say this is a bold play on words that hinges on the details of official wording in NHS paperwork.
The news comes amid a survey by campaign group Sling The Mesh which shows 83 per cent of women say they were not fully warned of risks or told they were having a permanent polypropylene plastic device.
Ruth Turner, a mum of two from Blackpool, agreed to speak out to blow the whistle on the “simple gold standard fix” after her surgeon at Blackpool Teaching Hospitals NHS Trust said women were jumping on the bandwagon of problems seen in America.
After two months of asking for a reaction, the hospital has today refused to comment.
A spokesman said: “After discussions we will not be making any response to the story.”
Ruth, 57, who works as an advocacy manager for deaf people, and a member of 5,600-strong Sling The Mesh campaign group, said: “My surgeon insisted he didn’t use mesh he was going to use a TVT tape made of polypropylene.
“It wasn’t until I joined Sling The Mesh I realised tape and mesh are the same thing and that polypropylene is plastic!”
She had a consultation in August last year but by October had seen press coverage so called her surgeons’ secretary to discuss it.
“She read a statement over the phone and insisted women were panicking with no good reason because it’s only the American mesh that causes problems.
“I was told he used tape not mesh and it wasn’t anything to do with the media hype and that women were missing out on a good treatment option.
“Had I not done my research and seen women with catastrophic, life changing pain, injuries and complications I would have been reassured and gone ahead and booked the operation.
“Luckily I cancelled. I dodged a bullet. There’s no way of telling who will suffer.
“Being a member of Sling The Mesh has shown me it’s nothing to do with age or build or if you have blue eyes or brown eyes or any other random reason.
“Nobody knows why, it’s Russian Roulette. It breaks my heart to see the terrible problems women are suffering, some with stomas, bladders removed, giving up work, losing their hobbies, in chronic pain.
“My active lifestyle defines who I am, I run and cycle, we are a really fit and active family. Had I lost all that over a simple operation I have no idea what I would have done.
“I would rather live with the problem than risk losing my quality of life.”
Official NHS coding calls incontinence mesh “introduction of a tension free vaginal tape”.
The word mesh is not used in paperwork so surgeons see this as a green light to deny they use it.
Campaigners say this is unethical.
Jackie Harvey,a campaigner from Northern Ireland, said: “The surgeon I saw in 2015 told me that my mesh wasn’t the same as the one in America that was causing all the issues.
“We see it time and again in groups globally that surgeons deny they use mesh, they are using tape - yet a TVT or TVTO tape is made of mesh. And that mesh is made of polypropylene, another word for plastic.
“It is a play on words.
“To deny they use the mesh in the media is arrogant and breaches trust. It breaks ethics under the Montgomery Ruling.”
• We contacted the media teams at Blackpool Victoria Hospital and the Royal College of Obstetrics and Gynaecology (RCOG) but have not received a response.
• There are almost 6,000 NHS surgeons working in obstetrics and gynaecology in the UK made up of:
- Consultants 44 per cent = 2,686
- Speciality doctors 25 per cent = 1,500
- Trainees 31 per cent = 1,858
• RCOG has 1,550 surgeon members in England, 65 in Northern Ireland, 150 in Scotland and 70 in Wales.
http://www.cambstimes.co.uk/news/surgeons-are-denying-they-use-mesh-by-caling-it-tape-in-the-vaginal-mesh-implant-scandal-1-5409989
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Vaginal Mesh Problems Prompt a Safety Audit in the UK
Feb 26, 2018 | MD+DI
By Amanda Pedersen
Prompted by public outrage over vaginal mesh complications, the U.K.'s health and social care secretary has called for a National Health System safety audit of the implants, which are used to treat prolapse and female urinary incontinence.
National Health System officials in the United Kingdom will be taking a hard look at the safety of mesh implants used to treat vaginal prolapse and female urinary incontinence. The U.K.'s health and social care secretary, Jeremy Hunt, ordered a safety audit of the devices in response to complaints from patients and their families asking for the products to be banned. The NHS will investigate the links between patient-level data to explore outcomes, and the organization will invest £1.1 million to develop a comprehensive database for vaginal mesh to improve clinical practice and identify issues.
Two other medical products, one being a hormone-based pregnancy test and the other being an epilepsy drug, will also be looked at.
"Many people have endured, and continue to endure, severe complications and tremendous pain, distress and ill health, alongside a strong sense that their concerns have not reached a satisfactory resolution," Hunt said during an address to the House of Commons. "I pay particular tribute to those who have responded to such experiences not just with understandable anger, but with a resolute determination to campaign for change on behalf of others."
The health secretary acknowledged that the response to these issues from those in public officials has not always been good enough.
"Sometimes the reaction has felt too focused on defending the status quo, rather than addressing the needs of patients, and as result patients and their families have spent too long feeling that they were not being listened to, making the agony of a complex medical situation even worse," Hunt said.
He said he asked Sally Davies, MD, chief medical officer at the NHS, for advice regarding a ban on vaginal mesh implants.
"She has been clear that clinical experts here and abroad agree that, when used appropriately, many women gain benefit from this intervention, hence a full ban is not the right answer in the light of the current evidence available," Hunt said.
On Primodos, the pregnancy test, Hunt said the organization will implement expert recommendations aimed at better monitoring of medicines in pregnancy. That will include offering families of the Association for Children Damaged by Hormone Pregnancy Tests a full and updated genetic clinical evaluation, better information for pregnant women and their families, better training and support for obstetricians, better evidence around dosing recommendations, making electronic yellow card reporting available directly to clinicians at the point of care, plus stronger and more "joined-up messages" on safety.
Complications related to vaginal mesh implants have cost companies like Johnson & Johnson and Bard(now part of BD) millions in lawsuits, but recently scientists at the University of Sheffield in the U.K. have developed an alternative polyurethane material to treat pelvic organ prolapse and incontinence that could be better suited for use in the pelvic floor.
https://www.mddionline.com/vaginal-mesh-problems-prompt-safety-audit-uk
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England’s top doctor reveals she suffered incontinence after her first child was born
Feb 27, 2018 | The Sun
By Nick McDermott
THE country’s top doctor has bravely told how she suffered incontinence after her first child was born.
England’s chief medical officer, spoke out in a discussion alongside Health Secretary Jeremy Hunt.
She said she gets many “tragic” letters from women in pain after dodgy vaginal implants — used to support the bladder.
Dame Sally, 68, said: “There’s undoubtedly been bad use of vaginal mesh.
“Women after babies can be damaged, so have incontinence.
“Actually, and I have never gone public about this, after my first child, I could walk three yards before I peed I my pants.
“For six weeks I could not leave the house. I’m still not as I’d wish to be so have every sympathy.”
Dame Sally said the treatment was appropriate for some, but too many were not told the risks.
Hundreds are suing the NHS over the ops and Mr Hunt ordered a review last week.
https://www.thesun.co.uk/news/5677846/englands-top-doctor-incontint-after-first-child-born/
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Country's most senior doctor reveals her bladder struggles after childbirth
Feb 27, 2018 | The Telegraph
By Laura Donnelly
The country’s most senior doctor has revealed her struggle with incontinence since the birth of her first child, as she said her "heart goes out" to women left in pain by subsequent surgery.
Dame Sally Davies, England’s chief medical officer, made the remarks during a discussion about medical errors.
Last week Jeremy Hunt ordered a concerns about medical treatments, including vaginal implants used to attempt to repair damage caused by childbirth.
Dame Sally said she had been inundated with “tragic” letters and emails from women left worse off by such surgery.
Hundreds are suing the NHS saying they have been left in agony by the implants.
During a discussion with Mr Hunt, she said: “We women, after we’ve had babies can be damaged so that we get incontinence and actually - I’ve never gone public about this - after my first child I could walk three yards before I peed in my pants.
“For six weeks I could not the leave the house. I’m still not as I would wish to be,” she said. “So i have every sympathy with these women.”
Some campaigners are calling for the mesh treatment to be banned.
The chief medical officer said the treatment was appropriate for some women, but said too often patients had not been properly counselled about the risk of side effects.
“It’s quite clear for a selected group of women that the best treatment if you have got a good doctor is a type of mesh that lifts the bladder up and supports the uterus and makes it all right,” she said.
“But even if you have got a good surgeon and the right patient there are quite a lot of side effects
15 to 20 per cent get side effects,” she said.
“I have a post bag over the weekend that is tragic - from women who have had the operation and are worse off. My heart goes out to them,” she said.
But she said the NHS needed to be very careful in examination of the evidence, because it was clear from many of the letters that risks of side-effects had not been discussed.
Last week a report commissioned by the Department of Health warned that NHS drug blunders may be causing up to 22,000 deaths a year.
The research led by the University of York, which analysed 36 major studies, suggests that more than seven in ten potentially harmful errors are being made by GPs and pharmacists, with patients ending up in hospital because they were prescribed the wrong drug.
The study estimates that avoidable drug errors are causing more than 700 deaths a year, and could be contributing to between 1,700 and 22,000 deaths.
In total, almost one in six hospital patients fell victim to a drug blunder, the research suggests.
https://www.telegraph.co.uk/news/2018/02/26/countrys-senior-doctor-reveals-bladder-struggles-childbirth/
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Researchers trial new pelvic prolapse treatment using stem cells, bioengineering
Feb 27, 2018 | ABC News
There is hope women who suffer from pelvic organ prolapse may be able to avoid surgery in the future after the discovery of a potential new treatment.
Described as a silent epidemic, the condition affects an estimated one in four women, with up to 19 per cent of Australian women requiring surgery for prolapse over their lifetime.
Australian scientists have now come up with a new experimental treatment, which uses stem cells from a woman's womb combined with nano-biomaterials to repair tissues damaged after child birth.
The new approach has been tested on sheep but is yet to be clinically trialled.
Professor Caroline Gargett from the Hudson Institute, who led the research, said it could one day offer a safer alternative to surgery.
"We think the research is hugely significant, because we might to be able to avoid many of these prolapse operations that are required later in life," she said.
"It's a huge shift in thinking in the way of treating this disorder."
Pelvic organ prolapse has often been treated with synthetic vaginal mesh implants, which were banned last year because of risks to patients.
The new technique uses a "platform" that mimics human tissue to house stem cells, which help the vagina repair itself.
"The materials that were previously used did not resemble native tissue … also they were non-degradable," said Shayanti Mukherjee, a research fellow at the Hudson Institute.
"The materials that we are using … integrate with the tissue very nicely because they are microscopically inspired from [the tissue itself]."
Current surgical techniques do not cure pelvic organ prolapse.
"For the majority [of affected women], there is a great improvement [following surgery], however there's a proportion of women where the prolapse comes back," said Anna Rosamilia, the head of Monash University's pelvic floor unit.
Up to a third of women who have undergone surgery for prolapse require further operations, she added.
Dr Rosamilia said the condition, which is a usually a consequence of injuries during childbirth, can cause significant problems if left untreated.
"It may be a problem at that time or it may be a problem 10, 20, 30 years later," she said.
"Women experience discomfort, vaginal bulge and it would interfere with their bladder, bowel, and it might obviously interfere with their sexual functions.
"In many cases, if it is left untreated and is very severe, it can have consequences not just for their social and personal life, but also for their physical health."
Sarah Monaghan, a mother affected by the condition, said her personal and family life had been affected.
"I haven't been able to work as much as before and I haven't been able to lift my daughter as much as I would like to," she said.
"It's a condition not talked about — people keep it hidden or [they] try to deal with it themselves or not deal with it at all.
"You definitely get judged a little bit. [It would be] absolutely fantastic to have [other] options for treatment."
Clinical trials are not expected for at least another three years.
http://www.abc.net.au/news/2018-02-27/pelvic-organ-prolapse-stem-cells-nanomaterial-trial/9489696
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